Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities.

ABSTRACT: Recent advances in immuno-oncology and regulatory approvals have been rapid and paradigm shifting in many difficult-to-treat malignancies. Despite immune checkpoint inhibitor therapy becoming the standard of care across multiple tumor types, there are many unanswered questions that need to be addressed before this therapeutic modality can be fully harnessed. Areas of limitations include treatment of patients not sufficiently represented in clinical trials, uncertainty of the optimal treatment dosing and duration, and lack of understanding regarding long-term immune related toxicities and atypical tumor responses. Patients such as those with autoimmune disease, chronic viral infections, limited performance status, and brain metastases were often excluded from initial trials due to concerns

SUBMITTER: Baik CS 

PROVIDER: S-EPMC5735832 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature